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A cohort study of efficacy, safety, and adherence of regimen containing efavirenz versus regimen containing efavirenz in HIV-1-positive initial treatment

A cohort study of efficacy, safety, and adherence of regimen containing efavirenz versus regimen containing efavirenz in HIV-1-positive initial treatment

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500113922
Enrollment
Unknown
Registered
2025-12-04
Start date
2024-03-26
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV infection

Interventions

ANV group:None
EFV group:None

Sponsors

Chest Hospital of Guangxi Zhuang Autonomous Region
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >=18 years old; 2.have been diagnosed as HIV-1 positive, have never received ARV treatment and have been judged by their physician to be suitable for ART treatment. 3.There were 90 cases (50% of the patients in this group) in which all the four test indicators of blood lipid were normal, or 90 cases (50% of the patients in this group) in which one of the four test indicators of blood lipid was in the borderline elevated range. 4.Those who can understand and comply with the requirements of the research program and voluntarily sign a written informed consent.

Exclusion criteria

Exclusion criteria: 1.Being treated with lipid-lowering drugs; 2.are using medications or treatments related to weight control; 3.people who currently have an AIDS-related disease and are receiving drugs metabolized by the CYP2C19 pathway; 4.Have a history of drug abuse, recent history of alcohol or drug dependence; 5.any situation that the investigator believes may endanger the safety of the subject or affect compliance with the test protocol; 6.Participants who have participated in clinical trials of other drugs or therapeutic devices within 30 days before being enrolled in this study; 7.Long-term (30 days or more) use of systemic immunosuppressive therapy or immunomodulators during the study period; 8.Alanine aminotransferase or aspartase > 5*ULN; 9.Creatinine >=1.5×ULN or creatinine clearance estimated by CKD-EPI formula 11.1mmol /L; 11.Have a history of allergy or hypersensitivity to any ingredient or excipient of the investigational drug; 12.suffering from major mental illness such as schizophrenia, epilepsy, major depression/anxiety; 13.With severe opportunistic infection, the researcher judged that it was not suitable to participate in the study; 14.Women who are pregnant or breastfeeding, and women of childbearing age who wish to have children within one year.

Design outcomes

Primary

MeasureTime frame
Virus load;CD4 T lymphocytes;

Secondary

MeasureTime frame
Baseline characteristics: including vital signs, weight, height, waist circumference, past medical history, smoking history, current comorbidities, concomitant medications, complete blood count, urinalysis, liver and kidney function, lipid profile, T-cell subsets, viral load, and cardiovascular disease risk factors.;Follow-up visits at 12, 24, 36, and 48 weeks collected data on vital signs, weight, height, waist circumference, current comorbidities, concomitant medications, complete blood count, urinalysis, liver and kidney function, lipid profile, adherence assessment, and adverse events.;

Countries

China

Contacts

Public ContactQin shanfang

Chest Hospital of Guangxi Zhuang Autonomous Region

2271976481@qq.com+86 772 3111659

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026